Evaluating the use of digitally enhanced treatment models in early intervention for youth with bipolar disorder.

Not Applicable

Not yet recruiting

• Conditions: Bipolar Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12623001272684
• Lead Sponsor: Orygen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-07
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1. Age 15 to 25 years.
2. Diagnosis of BD I or II.
3. Ability to provide informed consent and/or have a parent or guardian provide consent on their behalf.
4. Ability and willingness to nominate an emergency contact person, such as a close family member.

Exclusion Criteria

1. Has previously received 6-months of tertiary care through a mental health service or multi-disciplinary team for bipolar disorder or psychosis.
2. Currently requiring more than weekly clinical contact (for 4 weeks or more) or likely to require at least weekly clinical contact (for 4 weeks or more) in the next 6-months, due to high level of severity, complexity, or risk.
3. Experiencing psychosis or manic episode*
4. Intellectual disability that interferes with the likelihood of the participant receiving benefit from participation as judged by the treating clinician.
5. Inability to converse in or read English. English does not have to be the young person’s primary language.
6. Does not have access to the internet and an internet-enabled device.
7. High degree of hostility and impulsivity, as judged by the treating clinician, resulting in the clinician believing that inclusion in the research project may result in harm to the young person or other users (i.e., through interactions in the social network).
8. Has a schizophrenia spectrum diagnosis or a significant primary mental disorder that requires a different model of care, as determined by the clinical team.

*Those experiencing a (hypo)manic episode will be offered treatment, and upon remission, can be admitted to the study if they meet other eligibility criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of weeks in threshold mood episodes (either depressed, hypomanic, or a combination of both) over the 16-week period preceding the assessment.[Psychiatric Status Ratings (PSR) from the Longitudinal Interval Follow-up Evaluation (LIFE) modified for DSM-5. Threshold mood episode is defined as a PSR greater than or equal to five. Baseline and 2, 4, 6, 8, 10, 12 months from Baseline. Primary end-point is the end-of-treatment assessment at 8-months from Baseline.]